The present invention relates to compositions and methods for contact lens care and eye care. More particularly, the invention relates to compositions which include Vitamin derivatives useful as surfactants in such compositions and to methods of contact lens care and eye care using such compositions.
Nonionic surfactants are preferred for use in the contact lens care and eye care applications due to their relatively lower adverse interaction with contact lens polymers and ocular tissues than cationic, amphoteric and anionic surfactants. Nonionic surfactants are also preferred from the perspective of minimizing adverse interaction with cationic disinfecting agents, such as polyhexamethylene biguanide (PHMB) and the like, commonly employed in contact lens multi-purpose solutions.
Current surfactants used in contact lens multi-purpose solutions, re-wetting and in-the-eye cleaning solutions are exemplified by the surfactants disclosed in U.S. Pat. No. 4,836,986. This patent discloses that when used, the preferred neutral or non-ionic surfactants impart cleaning and conditioning properties and are usually present in amounts up to about 15 weight percent. The surfactant should be soluble in the lens care solution, non-irritating to eye tissues and usually have a hydrophilic-lipophile balance (HLB) of about 12.4 to about 18.8. Satisfactory non-ionic surfactants include, without limitation, polyethylene glycol esters of fatty acids, e.g. coconut, polysorbate, polyoxyethylene or polyoxypropylene ethers of high alkanes (C12-C18).
One group of non-ionic surfactants, poly(oxypropylene)-poly(oxyethylene) adducts of ethylene diamine having a molecular weight about 7,500 to about 27,000 wherein at least about 40 weight percent of the adducts is poly(oxyethylene), have been found to be particularly advantageous for use in cleaning and conditioning both soft and hard contact lenses when used in amounts from about 0.01 to about 15 weight percent. The CTFA Cosmetic Ingredient Dictionary's adopted name for this group of surfactants is poloxamines. Such surfactants are available from BASF Wyandotte Corp., Wyandotte, Mich., under the registered trademark “Tetronic”. An analogous series of surfactants is the poloxamer series, which are polyoxyethylene, polyoxypropylene block polymers available from BASF Wyandotte Corp., Parsippany, N.J. 07054 under the trademark “Pluronic”.
U.S. Pat. No. 4,820,352 discloses the use of poloxamine surfactants in general as cleaning agents in combination with biguanide disinfectants. U.S. Pat. Nos. 5,817,277, 5,593,637 and 5,422,073 disclose a contact lens multi-purpose solution comprising a polyhexamethylene biguanide (PHMB) disinfectant in combination with the surfactants tyloxapol, poloxamine, or poloxamer for cleaning and disinfecting contact lenses.
One concern with current contact lens care, in-the-eye rewetting, artificial tear solutions and eye wash compositions, and the surfactants therein, pertains to a lack of beneficial effects on ocular tissues. That is to say, existing surfactants perform, e.g. clean, well, but do not provide additional benefits to the ocular tissues with which they come in contact. Another concern with current surfactants pertains to systemic absorption. A significant amount of any solution, which is placed into the eye, is washed out, for example, through the naso-lacrimal ducts into the gastrointestinal tract, where systemic absorption can occur. Current surfactants, despite being compatible with lens care solutions and comfortable to the eye, are not known to be metabolically degraded or useful.
A number of patents disclose Vitamin E derivatives, some of which are surfactants. U.S. Pat. No. 5,179,122 discloses a nutritional supplement containing Vitamin E, a Vitamin E surfactant and an inert carrier. U.S. Pat. No. 5,235,073 discloses polyethoxylated Vitamin E with surfactant activity.
Several patents disclose Vitamin E or its derivatives in combination with preservatives of the same type utilized in contact lens care and ophthalmic applications. U.S. Pat. Nos. 5,653,695 and 6,046,143 disclose a medical device having a surface with a water soluble lubricant thereon and a water-soluble lubricant, the lubricant consisting of a silicone surfactant, Vitamin E or its derivatives and polyhexamethylenebiguanide to inhibit microbial growth. Vitamin E and its derivatives are disclosed as being oily products, which enhance the lubricity of the lubrication system. Water-soluble derivatives of Vitamin E, including Vitamin E surfactants, are not disclosed.
U.S. Pat. Nos. 5,603,929 and 5,653,972 disclose preserved, storage-stable ophthalmic compositions comprising acidic drugs, a polymeric quaternary ammonium compound and boric acid, and methods for controlling ocular inflammation using such compositions. Vitamin E tocopheryl polyethylene glycol 1000 succinate is disclosed as a formulation component. U.S. Pat. No. 5,886,030 discloses the use of Vitamin E tocopheryl derivatives, including Vitamin E tocopheryl polyethylene glycol 1000 succinate, in anti-inflammatory ophthalmic compositions. Methods are disclosed for treating or controlling ocular inflammation and for improving comfort and reducing irritation in compositions containing ophthalmic therapeutic agents, which are irritating to the eye. The compositions may include preservatives such as benzalkonium chloride, Polyquad™ and Dymed™ (polyhexamethylenebiguanide).
It would be advantageous to provide contact lens care compositions and compositions for use in the eye, and methods for using such compositions, including surfactants which provide one or more additional benefits, for example, to ocular tissues and/or systemically to the human or animal in whose eye the composition is placed.